Guidelines for Managing Changes in Manufacturing Vaginal Dosage Forms

1) Purpose

The purpose of this SOP is to define the procedures for managing changes in the manufacturing process, equipment, materials, and documentation of vaginal dosage forms to ensure consistency, compliance, and product quality.

2) Scope

This SOP applies to all changes affecting the manufacturing process, equipment, materials, and documentation of vaginal dosage forms within the pharmaceutical manufacturing facility.

3) Responsibilities

The Quality Assurance (QA) Department is responsible for overseeing the change control process. The Change Control Committee (CCC) evaluates and approves changes. Department Heads are responsible for initiating change requests and ensuring implementation.

4) Procedure

4.1 Initiating a Change Request

1. Identify the need for a change and document the rationale, including potential impact on product quality, compliance, and regulatory requirements.
2. Complete a Change Request Form (CRF) with details of the proposed change, including description, reason, impact assessment, and proposed implementation plan.
3. Submit the CRF to the QA Department for preliminary review.

4.2 Preliminary Review

1. The QA Department reviews the CRF for completeness and accuracy.
2. Conduct an initial impact assessment to determine the potential impact on product quality, compliance, and regulatory requirements.
3. If the preliminary review is satisfactory, forward the CRF to the Change Control Committee (CCC) for evaluation.

4.3 Evaluation by Change Control Committee (CCC)

1. The CCC evaluates the proposed change, considering factors such as product quality, compliance, regulatory impact, and overall risk.
2. Request additional information or clarification from the initiating department if necessary.
3. Approve, reject, or request modifications to the proposed change based on the evaluation.

4.4 Implementation Plan

1. Once approved by the CCC, develop a detailed implementation plan, including tasks, responsibilities, timelines, and required resources.
2. Ensure all relevant departments are informed of the approved change and their roles in the implementation plan.
3. Document the implementation plan and obtain necessary approvals from the relevant department heads.

4.5 Implementation and Documentation

1. Execute the implementation plan, ensuring all tasks are completed as per the defined timelines and responsibilities.
2. Document all steps taken during the implementation, including any deviations, corrective actions, and verification of completion.
3. Conduct any necessary training for personnel affected by the change.

4.6 Post-Implementation Review

1. Conduct a post-implementation review to ensure the change has been successfully implemented and objectives have been met.
2. Verify that there are no adverse effects on product quality, compliance, or regulatory requirements.
3. Document the findings of the post-implementation review and report them to the CCC and QA Department.

4.7 Closure of Change Request

1. Once the post-implementation review is satisfactory, close the Change Request Form (CRF).
2. Update relevant documentation, including SOPs, batch records, and training materials, to reflect the change.
3. Archive all change control documentation as per the document control SOP.

5) Abbreviations, if any

QA: Quality Assurance
CCC: Change Control Committee
CRF: Change Request Form

6) Documents, if any

Change Request Form (CRF), implementation plan, post-implementation review report

7) Reference, if any

ICH Q10: Pharmaceutical Quality System, WHO Technical Report Series No. 961, Annex 3: WHO guidelines on quality risk management

8) SOP Version

Version 1.0